Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
|Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer||Drug: Topotecan Drug: Gemcitabine||Phase 2|
|Study Design:||Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer|
- response rate
- response duration time to response time to progression survival safety
|Study Start Date:||December 2002|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061308
Show 19 Study Locations
|Study Director:||GSK Clinical Trials, MD, PhD||GlaxoSmithKline|